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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Anti-Vivisection Group Pressures Politicians Ahead of Election

With politicians hitting the campaign trail in the United Kingdom ahead of next month’s general election, anti-vivisection pressure group BUAV has resumed a push to get politicians to sign up to its manifesto. The campaign has raised fears for the future of research in the UK, but data suggest BUAV may prove to be no more influential than it was in the last election.

Pharmalot has posted an overview of both sides of the argument, in which a representative for BUAV argued the case for the organization’s six-point pledge to reduce animal testing and a critic warned the plan would “cripple” scientific progress. The row has been rumbling in the UK since BUAV began contacting candidates in the upcoming election late last year, but as it stands the high profile of the pledge appears out of step with its likely impact.

When Outsourcing-Pharma.com covered the story on March 31, 23 members of parliament (MPs) and 148 people standing in the upcoming election had signed BUAV’s Vote Cruelty Free pledge. The figures are well down from the corresponding period of the 2010 election cycle, during which BUAV ran a similar campaign. As early as December 2009, 21 MPs had signed an early day motion supporting Vote Cruelty Free, and by February of the following year 200 candidates had taken the pledge.

At the election in May 2010, 44 candidates out of the 413 who had by then backed Vote Cruelty Free were elected to parliament. The result meant almost 7% of elected officials had taken the pledge, but this has proven insufficient for BUAV to advance its agenda. If BUAV is to improve on its performance in 2010 and make an impact on animal research in the UK, it will need to increase the rate at which it signs up candidates in the last month of the election campaign. – Nick Paul Taylor

What do Regulatory Pros Need to Know About Personalized Medicines and Companion Diagnostics in the EU?

The shift from “one size fits all” medicinal products to more targeted and customized drugs is introducing new challenges for the people involved in the development and commercialization of such products.

One of those challenges: Knowing how to bring your personalized medicine product to market. Want to learn how? Attend this upcoming RAPS workshop and hear from experts and EMA regulators involved in the regulation of personalized medicine. Register by 11 May 2015 to attend this essential event. [Read More...]

MHRA to Require eCTD for Decentralized Procedure Applications

Starting on 1 July 2015, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) will only accept applications using the decentralized procedure in electronic common technical document (eCTD) format. The agency says that applications it receives after that date using other formats will be automatically rejected.

The requirement is not likely to affect most businesses, as 90% of the applications MHRA receives under the decentralized procedure are in eCTD format.

While this transition will not affect applications under the mutual recognition procedure, MHRA encourages companies to use the eCTD format for these applications as well, saying "the use of [non-eCTD] format for these applications is planned to be phased out by 1 January 2017." – Michael Mezher

Europe Braces for Indian Battle Against GVK ban

India has threatened to take commercial and legal action against Europe if regulators in the continent fail to revise their position on GVK Biosciences in light of evidence presented by officials in New Delhi. Representatives of the Indian government presented the evidence in meetings with the European Medicines Agency (EMA) and France’s ANSM.

The intervention of the Indian government raises the stakes in a row that appeared to have settled down in the wake of the EMA ruling earlier this year. However, the Indian government has spent the intervening months showing the echocardiograms at the center of the dispute to cardiologists, leading to it concluding the case against GVK is weak.

Now, it is ready to take action. “The European agencies have suspected the clinical trials on grounds that are absolutely flimsy,” Rajeev Kher, Indian commerce secretary, told The Hindu. “The past few years have seen a lot of action where the fault was not seen in the substance of the medicines but in the processes. We feel that this approach needs to be tempered.”

The reference to earlier actions is indicative of the context in which the Indian government views the GVK ban, which in its eyes is part of a broader campaign against its generics industry by multinational companies. – Nick Paul Taylor

German HTA Body Issues Opinion for Taqtiqom, Vargatef

The Institute for Quality and Efficiency in Health Care (IQWiG), a German health technology assessment (HTA) body, has completed its review of two new therapies.

For Santen's glaucoma and ocular hypertension drug Taqtiqom, a treatment that combines a prostaglandin analogue and a beta-blocker, IQWiG found the data presented in the dossier to be "uncertain" and "lacking." The issue, IQWiG says, is that the studies presented were unclear as to the proportion of patients who had been previously treated with either a prostaglandin analogue or beta-blocker monotherapy. As such, IQWiG says it cannot determine if there is an added benefit to the therapy as compared to other available treatments.

In the case of Boehringer Ingleheim's Vargatef plus docetaxel, used to treat advanced non-small cell lung cancer (NSCLC), IQWiG found the drug to have an added benefit in some circumstances, but said the drug appeared to be less effective than traditional chemotherapy plus docetaxel in patients with brain metastases.

For both products, the final determination as to the extent of added benefit lies with the Federal Joint Committee (G-BA), which will review the product dossiers along with IQWiG's opinions. – Michael Mezher

EMA Responds to Feedback on Insulin Biosimilar Guidelines

EMA has published a point-by-point response to comments on its draft guidelines covering the development of biosimilar insulins. EMA dismissed much of the feedback but accepted the need to revise some sections.

A handful of comments from the Dutch Medicines Evaluation Board about functional activity of IGF-1, the use of mitogenic activity as an endpoint and when in vivo studies are required, were accepted by EMA. The regulator also deleted a section on ethnic differences in endogenous insulin levels at the request of European Biopharmaceutical Enterprises, but for the most part rebuffed arguments about the need to make changes.

The publication of the feedback review process is one of the last steps before EMA begins to enforce the final guidelines, which will replace a document it introduced in the first wave of biosimilar advice back in 2006. The new guidelines are due to come into force on 1 September. – Nick Paul Taylor

MHRA Posts Medical Device Guidance for Hospitals

MHRA has published a 60-page guidance document to help hospitals and community organizations acquire, use, maintain and dispose of medical devices. The document covers factors hospitals should consider when sourcing medical devices and how to handle the reporting of adverse events.

The regulator also stresses the need for sites using medical devices to have a mechanism for sharing manufacturer Field Safety Notices across the organization. MHRA and manufacturers now frequently resend such notices because it is unclear whether end users have received and acted on the message.

A section of the guidance also encourages hospitals to establish a policy for trialing devices that are yet to receive a CE Mark. The policy should include measures to ensure investigational devices are kept separate from CE marked products. – Nick Paul Taylor

European Regulators Seek Input on Live Biotherapuetic Products

The European Directorate for the Quality of Medicines and Healthcare (EDQM) is looking for input from stakeholders involved with the development of "live biotherapeutic products," or products that rely on live microorganisms to treat or prevent diseases in human hosts.

The European Pharmacopoeia Commission's Working Party for Live Biotherapeutic Products hopes to use the input to develop a monograph for live biotherapeutic products. Stakeholders have until 30 April 2015 to submit their input via a survey on the EDQM website. – Michael Mezher

Irish Pharmacists Warn of Dangers of Codeine to Children

Pharmacists in Ireland have issued a warning to parents in response to the placing of new restrictions on codeine-based cough and cold remedies by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

Bernard Duggan, pharmacist and honorary treasurer of the Irish Pharmacy Union (IPU), said: “Coughs and colds are generally self-limiting conditions and the evidence that codeine is effective at treating cough is limited in children.”

Duggan also repeated PRAC’s advice to not give codeine to children below 12 years of age as a cough and cold remedy and avoid use in adolescents who suffer from breathing difficulties. Parents are advised to seek advice from a pharmacist before giving a codeine-based medicine to a child. – Nick Paul Taylor

Other News:

The European Commission has approved Roche’s Avastin in combination with chemotherapy to treat carcinoma of the cervix. Roche picked up the approval on the strength of a 452-person clinical trial, in which Avastin was associated with a 26% drop in the risk of death. The median survival of patients in the Avastin arm of the trial was 3.9 months longer than the control group. Press Release

MHRA and Mackworth Healthcare published a follow-up alert to users of slings fitted with the latter’s Dosec clips. Mackworth posted a notice in February to inform users of the publication of a general safety guide and highlight the need to read it before using the sling for the first time. However, the firm has received too few responses to give it confidence users received the message. Safety Alert

EMA touted its efforts to ensure food safety on World Health Day 2015, discussing its efforts to boost animal vaccine development and promote responsible use of antimicrobial products in animal populations. Press Release